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Information provided by (Responsible Party):

Michal L. Melamed, Albert Einstein College of Medicine of Yeshiva University

Patients randomized to this arm will receive a placebo pill once weekly.

Other: Placebo

Patients randomized to this arm will receive one placebo pill once weekly.

Detailed Description:

This RCT will enroll 75 subjects, men and women over age of 18, with stage 3-4 CKD from various causes including diabetes and hypertension. Patients will be recruited from the Montefiore Medical Center Nephrology clinics and the Montefiore Medical Center internal medicine clinics and other interested individuals.

Informed consent will be obtained on all subjects. All subjects with meet with one of the investigators who will verbally explain to them the purpose of the study and the alternatives.

Blood and urine tests will be collected to assess for proteinuria, vitamin D levels, serum creatinine, calcium and phosphorus, as well as a urine albumin, calcium and creatinine. These tests will be used for experimental purposes only and will be collected at each study visit over the span of 6 months.

There will be two arms, an arm randomized to 50000IU of ergocalciferol once weekly and a placebo arm for 3 months. For an additional 3 months, all patients will be repleted with Vitamin D via open-label extension, based on their levels after 3 months.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age >18 years

Ability to provide informed consent

Chronic kidney disease stage 3 and 4

On ACE inhibitor or ARB for albuminuria if tolerated

Assessed during eligibility screen:

Albuminuria >30 mg/g creatinine

25(OH) vitamin D level >12.5 and <75 nmol/L

Exclusion Criteria:

On vitamin D in past 4 weeks

Plans to relocate out of New York City in the next 6 months

25 (OH) Vitamin D level <12.5 nmol/L

HIV infection

History of hypercalcemia or kidney stones

Serum phosphate >5.5 mg/dl in past 3 months

Serum calcium >10.0 mg/dl in past 3 months

SBP >160 DBP >100 at screening visit

Transplanted organ

Cancer

Polycystic kidney disease

Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029002

Locations

United States, New York

Montefiore medical center

Bronx, New York, United States, 10467

Sponsors and Collaborators

Albert Einstein College of Medicine, Inc.

Investigators

Principal Investigator:

Michal Melamed, MD, MHS

Albert Einstein College of Medicine, Inc.

More Information

Responsible Party:

Michal L. Melamed, Assistant Professor, Albert Einstein College of Medicine of Yeshiva University